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FDA 510(k)

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

K-Number: K072932 · 2008-04-25

ApplicantInfraredx, Inc.
Decision Date2008-04-25
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2008-04-25 under 510(k) number K072932. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5?

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 is a medical device that received FDA 510(k) clearance on 2008-04-25. The listed applicant is Infraredx, Inc.. The 510(k) number is K072932.

When did INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 receive FDA 510(k) clearance?

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 received FDA 510(k) clearance on 2008-04-25, under 510(k) number K072932.

Who is the listed applicant for INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5?

The FDA 510(k) record lists Infraredx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5?

The FDA product code for INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 is OGZ.

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Other records listing Infraredx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterK163345TVC Imaging System, TVC CatheterK130719TVC IMAGING SYSTEM, TVC INSIGHT CATHETERK123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70

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Related Devices (Code: OGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )Infraredx, Inc.K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterInfraredx, Inc.K163345TVC Imaging System, TVC CatheterInfraredx, Inc.K130719TVC IMAGING SYSTEM, TVC INSIGHT CATHETERInfraredx, Inc.K123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70Infraredx, Inc.K093993LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70Infraredx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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